Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus

NCT05988216 | Recruiting

• 1 other identifier: 2022-BRL-301A-SLE-IIT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• The safety of BRL-301 in refractory systemic lupus erythematosus

  Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs as assessed by CTCAE v5.0.

  3 months

Secondary Outcomes (2)

• The efficiency of BRL-301 in refractory systemic lupus erythematosus

  3 months

• Cellular kinetics

  3 months

Study Arms (1)

BRL-301

EXPERIMENTAL

Allogeneic CD19-targeted Chimeric AntigenReceptor (CAR) T Cells

Biological: BRL-301

Interventions

BRL-301 BIOLOGICAL

Single dose of Allogeneic Anti-CD19 CAR T cells will be infused

Also known as: Allogeneic Anti-CD19 CAR T cells

BRL-301

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 65 years old (including threshold), regardless of gender;
• Subjects diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria; ANA ≥ 1:80, or positive for anti dsDNA and/or anti Sm antibodies;
• The condition becomes active again after conventional treatment is ineffective or the disease relapses. Conventional treatment is defined as the use of two or more drugs, including corticosteroids (more than 1mg/kg/d) and any one or more of the following immunomodulatory drugs for over six months: antimalarial drugs, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics including rituximab, belimumab, etanercept, etc.
• At least one BILAG2004 Class A or two Class B score, or both;
• SELENA-SLEDAI score ≥ 8 points;
• The positive expression and expression rate of CD19 on peripheral blood B cells determined by flow cytometry;
• The functions of important organs meet the following requirements:
• Bone marrow function needs to meet:
• White blood cell count ≥ 3 × 109/L;
• Neutrophil count ≥ 1 × 109/L (no Colony-stimulating factor treatment within 2 weeks before examination);
• Platelets ≥ 50 × 109/L;d. Hemoglobin ≥ 80g/L
• Liver function:
• Alanine Aminotransferase (ALT) ≤ 3 × ULN;
• Asparagus cochinchinensis transase (AST) ≤ 3 × ULN;
• Total Bilirubin (TBIL) in serum ≤ 1.5 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN); Renal function: Creatinine Clearance Rate (CrCl) ≥ 60 ml/minute (Cockcroft/Fault formula) ;

You may not qualify if:

• Have a serious history of Drug allergy or allergic constitution;
• Fungi, bacteria, viruses, or other infections that are uncontrollable or require intravenous medication treatment exist or are suspected;
• Active central nervous system disease caused by SLE or not (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system Vasculitis);
• Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
• Subjects with congenital immunoglobulin deficiency;
• Other malignant tumors (excluding non Melanoma skin cancer, cervical cancer in situ, bladder cancer cancer and breast cancer that have survived for more than 5 years without disease);
• Subjects with end-stage renal failure;
• Have received any of the following SLE treatments:
• Corticosteroid (defined as prednisone or equivalent\>20 mg/day) of therapeutic dose were used before enrollment or within 72 hours before BRL-301 infusion.
• Use any other clinical study drugs for SLE within 4 weeks prior to enrollment. However, if the research treatment period is ineffective or the disease progresses, and at least 3 half-lives have passed before enrollment, enrollment is allowed.
• Had received anti CD20 monoclonal antibody (such as Rituximab) within 4 weeks before screening, tetaximab within 6 weeks, or belizumab within 12 weeks.
• Previous CAR-T cell or other genetically modified T Cell therapy.
• Subjects with positive hepatitis B B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;
• Having mental illness and severe cognitive impairment;
• Those who have participated in other clinical trials within the first 3 months of enrollment;

Sponsors & Collaborators

• Bioray Laboratories: lead
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hongyan Tong, Doctor

CONTACT

8613958122357; hongyantong@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: August 14, 2023
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)